EMA Issues Favorable Opinion on Conditional Marketing in Europe for Investigational MM Bispecific Antibody

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the possibility of conditional marketing authorization from the European Commission for linvoseltamab. This opinion from the CHMP pertains specifically to use for relapsed and refractory multiple myeloma (MM) in adults who have undergone at least three prior therapies, including an anti-CD38 monoclonal antibody, an immunomodulatory agent, and a proteasome inhibitor.

This recommendation from the CHMP was announced in a press release from Regeneron Pharmaceuticals. Linvoseltamab is an investigational B-cell maturation antigen (BCMA) x CD3 bispecific antibody, which Regeneron developed using a proprietary humanized mouse immune system genetic engineering platform.

The Committee’s opinion was partly based on favorable results from the ongoing open-label LINKER-MM1 clinical trial, which evaluated linvoseltamab efficacy and safety in adults with relapsed or refractory MM. The phase 1 dose escalation portion of this trial is complete, and its phase 2 dose expansion component is underway to evaluate the agent with a primary endpoint of objective response rate.

Regeneron is conducting additional clinical trials to investigate linvoseltamab across different lines of therapy in MM. For the management of relapsed or refractory disease, the phase 3 confirmatory trial LINKER-MM3 evaluates the use of the agent as monotherapy, while the phase 1b LINKER-MM2 trial assesses it in combination with other cancer treatments.

Linvoseltamab has not yet received approval from any regulatory agency, but the European Commission is expected to announce a final decision in the coming months regarding a conditional marketing authorization for linvoseltamab. In February 2025, the US FDA accepted for review a Biologics License Application (BLA) for linvoseltamab to manage relapsed or refractory MM, with a target decision action date of July 10, 2025.

Reference

Linvoseltamab recommended for EU approval by the CHMP to treat relapsed/refractory multiple myeloma. Press release. Regeneron Pharmaceuticals, Inc. February 28, 2025. Accessed February 28, 2025. https://www.globenewswire.com/news-release/2025/02/28/3034628/0/en/Linvoseltamab-Recommended-for-EU-Approval-by-the-CHMP-to-Treat-Relapsed-Refractory-Multiple-Myeloma.html